The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0690-2023·Announced 2022-12-21

FDA Recalls DeRoyal CNRV Spinal Pack Medical Devices

DeRoyal has voluntarily recalled 69 kits of CNRV Spinal Pack medical devices distributed to 23 US states. The manufacturer initiated the recall on November 3, 2022.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA medical device recall for a surgical spinal pack, which is inherently a risk-of-harm product. No illnesses or injuries are reported in the source documentation. Per the severity rubric, risk-of-harm products without reported injuries qualify for score 3.

Plain-English summary

DeRoyal Industries Inc initiated a voluntary recall of 69 kits of the CNRV SPINAL PACK medical device (reference 89-10532.03) on November 3, 2022. The affected lot numbers are Lot 57188745 (expires 3/1/2024), Lot 57393378 (expires 5/1/2024), and Lot 57663075 (expires 5/1/2024). The FDA classified this as a Class II recall.

The devices were distributed across 23 US states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.

Healthcare facilities and providers who have received these devices should contact DeRoyal Industries Inc or the FDA with any questions or for recall instructions. The recall remains ongoing.

The recalled product

Product
DeRoyal CNRV SPINAL PACK, REF 89-10532.03
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Spinal
Affected units
69

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot Numbers: Lot 57188745 exp 3/1/2024
  • Lot 57393378 exp 5/1/2024
  • Lot 57663075 exp 05/01/2024

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 156 products in this recall →

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